Effect of Tai Chi Exercise on Mechanical Joint Loading in Knee Osteoarthritis

February 13, 2023 updated by: Edward Via Virginia College of Osteopathic Medicine

Real Time Biofeedback Tai Chi Training for Knee Osteoarthritis: A Feasibility Study

This project is designed to identify the biomechanical mechanisms of Tai Chi (TC) exercise and test a novel optimized TC intervention by modifying newly identified mechanisms for those with knee osteoarthritis (OA) and to assess the changes in mechanical load with the intervention. It combines unique real time torque biofeedback approach, and uses external knee adduction moment (EKAM) as modulation target tailored to TC intervention in this population. The potential benefit from this project is to provide biomechanical insights of TC and this novel TC approach may produce meaningful changes of mechanical load in these patients who can learn and practice safely during this intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Disabilities that arise from typical impairments of knee osteoarthritis (OA) include decreased muscle strength, reduced range of motion, and decreased aerobic cardiovascular function. A large number of individuals with knee OA experience disability and require rehabilitation. Traditional TC intervention has been a promising therapeutic intervention in knee OA, but the efficacy of TC as a knee OA intervention has proven inconclusive presumably because individuals with knee OA perform different TC components (steps) with widely varying mechanical knee joint loads. This variation could be a confounding factor in the way in which TC affects knee OA. Therefore, a feasibility study is proposed here to quantify external knee adduction moment (EKAM) response to the different TC steps, and then determine if it is feasible to use biofeedback of torque acting on the knee to modify some TC steps so as to reduce the EKAM they produce. Those TC steps whose EKAM can be easily reduced below mean EKAM during walking and those already below that level will constitute an optimized form of TC for knee OA; the remainder will be discarded. A phase 1 randomized controlled trial will be conducted to compare the optimized TC intervention to traditional TC training in reducing EKAM. The proposed research represents the first study to identify the biomechanical mechanisms of TC and to target EKAM by using a real-time biofeedback approach to manipulate EKAM during TC performance.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • UT Health San Antonio, Rehabilitation Biomechanics Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OA participants will be diagnosed based on the American College of Rheumatology classification criteria.
  • Knee pain average level > 3 cm on a 10 cm visual analog scale,
  • Kellgren / Lawrence scale of 2-3 on radiographs.
  • Pain/tenderness over the medial region or lateral region of the knee on physical examination.
  • The participants will have 40 years of age or older and have no TCC experience prior this study.

Exclusion Criteria:

  • a history of lower extremity joint replacement
  • intra-articular knee injection (steroid, hyaluronic acid) within the previous 6 months
  • systemic rheumatoid arthritic condition affecting the knee clinically or radiographically,
  • report of any of the following health problems (heart condition, chest pain during periods of activity or rest)
  • currently seeking or receiving physical therapy for knee OA,
  • having a medical condition precluding the participant from undergoing physical activity or biomechanical gait analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: optimized Tai Chi intervention
Behavioral: Optimized Tai Chi intervention
Optimized Tai Chi intervention
Other Names:
  • OTC
Active Comparator: traditional Tai Chi intervention
Behavioral: Traditional Tai Chi intervention
Traditional Tai Chi intervention
Other Names:
  • TTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline knee joint mechanical load at 4 weeks
Time Frame: baseline and 4 weeks
knee joint mechanical load will be measured by using high speed cameras and force plates to estimate external knee adduction moment (EKAM)
baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Via Virginia College of Osteopathic Medicine

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-050
  • 1K23AT009568-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary outcome measure will be made available

IPD Sharing Time Frame

Data will be available within 6 month of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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